MAUDE Adverse Event Report: MORTARA INSTRUMENT QS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML; ELECTROCARDIOGRAPH

Model Number	QS6-MLTC1
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted baxter to report the nurse had saved an exam with the incorrect patient information.There was no adverse event.
Additional Manufacturer Narrative
Technical services walked the customer through correcting the exam by using the 'reconcile' feature in qstress.The customer confirmed the correct exam now contains the correct patient demographics.The qstress 6 system is a pc based diagnostic tool intended to acquire, process, and store ecg data of patients undergoing cardiac or cardio-pulmonary stress testing.The software records ecg, heart rate, and st data, creates summary tables, trends and a final report regarding a variety of cardiac data indices.The cardiac data provided is reviewed, confirmed, and used by trained medical personnel to assist in the diagnosis of the electrocardiographic data reflecting the patient's physiological condition during cardiac stress testing.Although there was no device malfunction found and the incident was determined to be due to use error, if an exam were to contain incorrect patient details it could cause or contribute to a death or serious injury if this were to recur.

• Brand Name: QS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML
• Common Device Name: ELECTROCARDIOGRAPH
• Manufacturer (Section D): MORTARA INSTRUMENT; 7865 n 86th street; milwaukee WI 53224
• Manufacturer Contact: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 23070644
• Report Number: 2183461-2025-00013
• Device Sequence Number: 4748704
• Product Code: DPS
• UDI-Device Identifier: 00812345027631
• UDI-Public: 812345027631
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: QS6-MLTC1
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 09/17/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown